Statistical Analysis Plan

Sufficient data need to be available in order to perform the planned statistical analysis. Rules for assessing the so-called maturity of the data need to be specified upfront in the SAP. Depending on the type of endpoint, this may refer to a certain number of patients with a pre-specified follow-up time (e.g. one year after the last patient was registered) or when the pre-specified number of events needed for the primary outcome analysis is reached, as is often done in the case of a time-to-event endpoint.